Job Description :

The Role:

Reporting to the Associate Director, Quality Systems, the GxP Quality Systems Engineer will serve as a support of the technical design, development, delivery and maintenance of the GxP Compliance Systems - Quality Management, Document Management, Validation System Management. This position will play a key role in maintaining systems and the integrated processes to support the overall digital / IT QA compliance systems landscape.

 

Here's What You'll Do:

System administrator support for the day-to-day administration of Veeva Quality Vault and Kneat Validation Management System.

Monitor help desk requests and incidents to troubleshoot critical production issues impacting end-users, including system lifecycles, workflows, security settings and object issues.

Work directly with the SaaS support teams to bring open service issues to a resolution by triage and monitoring progress.

Support issue resolution, continuous process improvements and routine system updates of Veeva Quality Vaults and other compliance systems.

Consult with the compliance business areas on development and managed deployment of system enhancements to ensure efficient usage and maintenance of technology.

Ensure current system functionality is maintained and assess impact and integrity of introducing new functionality into systems.

Support requirement definition and provide technical design insight within the applications and integrations between compliance systems other GxP systems (ERP, LIMS and MES) and Partner Systems.

Create and maintain GxP computer system deliverables including user requirements, system specifications and validation test scripts.

Perform system sandbox testing and participate in formal system validation testing execution.

Assist in system assessments quarterly or yearly to support vendor software releases and patches.

Report and management any issues/bugs in the applications to Vendors and assist in troubleshooting and testing.

Provide support for planned and unplanned inspections/audits.

 

Here's What You'll Bring to the Table:

A bachelor's degree in science, technology or another relevant academic discipline.

8 years of experience implementing and maintaining technology to support GxP QS processes.

Excellent interpersonal and communication skills with ability to work collaboratively within a team of stakeholders and influence decisions.

Must have a customer service mindset.

Quality orientated with strong attention toward details.

Ability to interact well with other groups and must be able to take ownership of and follow through on assignments.

Self-directed with effective analytical and problem-solving skills. 

Must be able to drive results on multiple complex assignments simultaneously with minimal required direction.

Understanding of industry technology trends in quality management, document management and learning management.

Experience with Veeva Vaults (eTMF, Quality (Docs and eQMS). Experience with SAP SuccessFactors learning management, Please Review and Validation Management System (Kneat) is a plus.

Understanding of roles and security required when developing or customizing objects.

Expertise with computer systems validation practices (GAMP).

API, data report development and systems integration.

Technical writing skills required.

Capable of operating within a fast-moving business environment.

             

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